On August 8, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the second quarter ending June 30, 2019 and provided a business update (Press release, Savara, AUG 8, 2019, View Source [SID1234538548]).

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"Our highest corporate priority continues to be the Molgradex aPAP program," said Rob Neville, Chief Executive Officer, Savara. "While the IMPALA study did not achieve statistical significance on its pre-specified primary endpoint, the totality of the efficacy data are encouraging and reinforce the important role of Molgradex to improve oxygenation and reduce surfactant burden in these patients. Additionally, with adverse event frequencies similar to placebo, we believe this drug has a compelling risk-benefit profile. We are proceeding with regulatory interactions to determine the best path forward, while simultaneously preparing for an additional Phase 3 study should that be required."

Recent Developments and Upcoming Highlights

Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP)

Reported top line results from IMPALA, a pivotal Phase 3 clinical study.
Granted a Type C meeting with the FDA, expect written responses from the agency in October 2019.
Anticipate filing for Breakthrough Designation in the U.S.
Continued strong enrollment in IMPALA-X, an open-label, multicenter extension study to determine the long-term safety and utilization of Molgradex in patients with aPAP. 32 out of 35 eligible patients have enrolled in the extension study, with no whole lung lavages reported and no drop-outs to-date.
Molgradex for nontuberculous mycobacterial (NTM) lung infection

Expect top line results from OPTIMA, a Phase 2a clinical study evaluating Molgradex for the treatment of NTM in non-cystic fibrosis (CF) patients, in Q1 2020.
AeroVanc

Revised enrollment completion guidance for AVAIL, a pivotal Phase 3 clinical study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF.
― As of August 1, 2019, the study has enrolled 168 patients out of a target of 200. The approximate 50% screen failure rate with younger subjects has slowed enrollment. The screen failures are largely due to exacerbations between time of screening and randomization.
― Expect to complete patient enrollment in the first half of 2020 with top line results now expected in late 2020 or early 2021.
Exploratory Pipeline

Deprioritized the amikacin/fosfomycin program in order to focus resources on the Company’s later stage programs. Future development will be considered at a later time.
Second Quarter Financial Results (Unaudited)

Savara’s net loss attributable to common stockholders for the three months ended June 30, 2019 was $21.9 million, or $(0.57) per share, compared with a net loss attributable to common stockholders of $11.6 million, or $(0.37) per share, for the three months ended June 30, 2018.

Research and development expenses were $10.5 million for the three months ended June 30, 2019, compared with $9.3 million for the three months ended June 30, 2018. The increase was primarily due to $2.2 million in increased development costs associated with the development of Molgradex and AeroVanc, which was partially offset by $1.0 million in expense in the form of common stock issued in connection with an asset purchase in the second quarter of 2018.

General and administrative expenses for the three months ended June 30, 2019 were $4.2 million, compared with $2.5 million for the three months ended June 30, 2018. The increase was primarily due to increased personnel costs and other legal, accounting, insurance, commercial strategy, business development, and operating activities.

During the three months ended June 30, 2019, we recognized a $7.4 million non-cash impairment charge to the carrying value of our goodwill following the results of our IMPALA study.

As of June 30, 2019, Savara had a carrying value of its debt of approximately $24.8 million and had cash, cash equivalents, and short-term investments of approximately $111.7 million. Under the current operating plan, the Company believes this is sufficient capital to fund planned operations into 2021.

Conference Call and Webcast

Savara will host a conference call today at 4:30 p.m. Eastern Time (ET)/1:30 p.m. Pacific Time (PT). Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the "Savara Inc." call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source

Approximately one hour after the call, a replay of the webcast will be available on Savara’s website for 30 days, and a telephone replay will be available through August 15, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10133438.

On August 8, 2019 LineaRx reported that it has acquired the assets and intellectual property of Vitatex, a developer of invasive circulating tumor cell (iCTC) analysis technologies (Press release, Vitatex, AUG 8, 2019, View Source [SID1234538579]).

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According to LineaRx — an Applied DNA Sciences subsidiary formed around technologies for DNA design, manufacture, and chemical modification by large scale PCR — Vitatex’s technologies allows iCTCs to be isolated from standard blood samples. These cells can then be cultured and challenged against panels of cancer therapies to help personalize treatments, such as CAR T immunotherapies, for specific patients.

Following the acquisition, LineaRx said that it will work with other companies to enhance their cancer assays, generate personalized redirected cell therapies against cancers with high mutation burdens and metastatic potential, out-license Vitatex’s technologies for use in early cancer diagnostics and prognostics, and design synthetic genes to redirect immune cells against antigens that are recognized by leukocytes that comigrate with iCTCs. It also aims to develop therapeutics that use its proprietary DNA manufacturing methods.

On August 8, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the second quarter ended June 30, 2019 and provided a business update(Press release, Adamis Pharmaceuticals, AUG 8, 2019, View Source [SID1234538409]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "I believe the most significant event in the second quarter was Sandoz’s full launch of our SYMJEPITM epinephrine injection product in the U.S. The retail launch in July, made both doses of SYMJEPI available for patients and caregivers. With shortages in the market over the last year, we hope SYMJEPI can help meet the demand for this potentially lifesaving drug. We also are looking forward to a potential FDA approval for our ZIMHITM naloxone injection product candidate. If approved, we hope to be in position to assist in the effort to combat the ongoing public health crisis of opioid overdose."

"Also noteworthy was the recent resolution of all the outstanding patent litigation relating SYMJEPI and ZIMHI. In addition, by closing the public offering that we announced last week, we added additional cash to our balance sheet to provide the necessary runway to give the company the best chance to achieve some of our near-term goals and the potential for revenue growth from SYMJEPI and our U.S. Compounding division to reach levels that could bring us to our goal of profitability."

Product Updates

SYMJEPI (epinephrine) Injection

On July 9, 2019, Sandoz announced the full launch of our SYMJEPI epinephrine injection product in the U.S., making both the 0.3mg and 0.15mg doses available in local pharmacies across the nation. The company is hopeful that Sandoz’s marketing efforts, combined with the ongoing shortage of epinephrine injection products in the market will begin to increase sales of SYMJEPI and cash to Adamis by the end of 2019.

ZIMHI (naloxone) Injection

On March 14, 2019, Adamis announced that the FDA had accepted the company’s New Drug Application (NDA) for review and provided a target agency action date (PDUFA) of October 31, 2019. The company believes that if approved, ZIMHI could be an important part of the solution to this growing health crisis of opioid overdose. The company is in discussions with several potential partners for ZIMHI with the goal of finalizing a commercial distribution agreement for the U.S. prior to a potential approval.

Drug Outsourcing Facility

During the second quarter of 2019, the company’s wholly owned drug outsourcing facility, US Compounding (USC), continued to grow revenues and margins. USC continued to improve in the second quarter and the company expects the division to be net positive for Adamis in the second half of 2019.

Other Developments

On July 18, 2019, Adamis announced it had settled all pending litigation with kaléo Inc. As part of the settlement the parties agreed to voluntarily dismiss both the pending patent and trademark cases. Furthermore, kaléo agreed not to bring future action against Adamis relating to ZIMHI so long as Adamis does not reference kaléo’s product in a future filing with the FDA. In turn, Adamis agreed not to bring future action against kaléo for acts that occurred prior to the settlement.

On July 24, 2019, the company announced it had settled all pending litigation with Belcher Pharmaceuticals regarding certain Belcher patents relating to methods of preparing epinephrine. As part of the settlement Belcher provided Adamis a worldwide, non-exclusive, fully paid-up, royalty-free license for certain patent claims relating to SYMJEPI and agreed not to bring future action against Adamis relating to ZIMHI. In exchange Adamis agreed to voluntarily withdraw both the patent case in Florida and the IPR filed with the United States Patent and Trademark Office.

Second Quarter 2019 Financial Results

Revenues for the second quarter grew 17.5% over the first quarter of 2019 (approximately $5.8 million and $4.9 million, respectively), and increased 47.0% over the $3.9 million for the comparable period of 2018. The increase was primarily attributable to continued growth in sales of USC’s sterile pharmaceutical products and manufacturing revenue relating to the non-retail launch of SYMJEPI.

Selling, general and administrative expenses during the second quarter of 2019 decreased 12.7% from the first quarter of 2019 (approximately $7.0 million and $8.0 million, respectively). This decrease was mostly the result of restructuring, including reductions of personnel, at USC.

Research and development ("R&D") expenses were approximately $2.8 million for the second quarter of 2019 compared to approximately $2.2 million in the first quarter of 2019; however, R&D expenses decreased 41.2% from the same quarter in 2018. We anticipate that R&D expenses will decrease in the second half of 2019.

Cash and equivalents at the end of the second quarter was approximately $4.1 million, and net proceeds from last week’s firm commitment underwritten public offering transaction were approximately $12.7 million. Our goal for the second half of 2019 is to keep cash expenditures, that is, cash used in operating and investing activities, in the range of $7 – 8 million. If we meet our spending goals for the remainder of 2019, it should represent a reduction of approximately 37% from the Net Cash used in Operating and Investing Activities for the comparable period of 2018.

Targeted Milestones for Remainder of 2019

● Growth in sales of the SYMJEPI in the U.S.
● FDA approval for ZIMHI
● Commercial partner for ZIMHI
● Commercial partner(s) for SYMJEPI for territories outside of the U.S.
● US Compounding begins to contribute cash to Adamis

Conference Call

Adamis will host a conference call and live webcast today, August 8, 2019 at 2:00 pm PDT (5:00 pm EDT) to discuss its financial and operating results for the second quarter 2019, as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-866-288-0540

TOLL/International Dial-In: 1-323-994-2131

Conference ID: 4399286

Webcast: View Source

If you are unable to participate in the call live, a telephone playback will be available after approximately 5:00 pm PDT on August 8, 2019. To listen to the replay, call toll free 1-844-512-2921 within the U.S. or 1-412-317-6671 internationally (toll) and enter PIN number 4399286.

On August 8, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the second quarter of 2019 (Press release, Navidea Biopharmaceuticals, AUG 8, 2019, View Source [SID1234538425]). Navidea reported total revenues for the quarter of $260,000. Net loss attributable to common stockholders was $2.7 million.

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"During the second quarter, Navidea continued to deliver on its renewed focus to complete its NAV 3-31 trial and raise the funding to cover it," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The Company furthered its partnership discussions around the globe but most importantly Navidea met its internal recruiting and enrollment goals for its ongoing RA trials. The Company remains focused on bringing its RA diagnostic to market."

Second Quarter 2019 Highlights and Subsequent Events

Effected a one-for-twenty reverse stock split and received notification of stock price compliance from the NYSE American

Announced that results of the Company’s NAV3-21 clinical study for diagnosis of rheumatoid arthritis were presented at the Society of Nuclear Medicine and Molecular Imaging ("SNMMI") Annual Meeting by Arash Kardan, M.D.

Completed an underwritten public offering with gross proceeds of $6.0 million

Achieved double-digit subject enrollment in our NAV3-31 Phase 2b study and are on track with recruitment projections to date

Received an Intent to Fund notification from the National Heart, Lung and Blood Institute for its Small Business Technology Transfer Phase 1 grant application that will support a collaboration with the University of Alabama at Birmingham titled "Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques"

"We were extremely pleased with the recognition received at the annual SNMMI meeting following our Phase 1 and 2 study results, and we are pressing forward with recruitment in the ongoing Phase 2B," said Dr. Michael Rosol, Chief Medical Officer of Navidea. "This Phase 2b study will provide the fundamental test-retest and longitudinal data to validate our power calculations for the upcoming Phase 3 trial."

Financial Results

Our consolidated balance sheets, statements of operations, and statements of stockholders’ equity have been restated, as required, for all periods presented to reflect the reverse stock split as if it had occurred on January 1, 2018. Our consolidated statements of cash flows were not impacted by the reverse stock split.

Total revenues for the second quarter of 2019 were $260,000, compared to $542,000 in the same period of 2018. Total revenues for the first six months of 2019 were $302,000, compared to $819,000 in the same period of 2018. The decrease was primarily due to a decrease in license revenue related to the sublicense of our NAV4694 technology which included a non-refundable upfront payment in 2018, coupled with a reduction in grant revenue related to SBIR grants from the NIH supporting Manocept development.

Research and development ("R&D") expenses were approximately $1.1 million in each of the second quarters of 2019 and 2018. R&D expenses for the first six months of 2019 were $1.8 million, compared to $2.1 million in the same period of 2018. The year-to-date decrease was primarily due to net decreases in drug project expenses including therapeutics, Tc99m tilmanocept, and NAV4694 development costs, offset by increased Manocept diagnostic development costs. The net decrease in R&D expenses also included decreased compensation costs resulting from net decreased salaries and headcount.

Selling, general and administrative ("SG&A") expenses for the second quarter of 2019 were $1.9 million, compared to $1.8 million in the same period of 2018. SG&A expenses were approximately $3.6 million in each of the first six months of 2019 and 2018. Increased legal and professional services were offset by decreased compensation costs.

Navidea’s net loss attributable to common stockholders for the second quarter of 2019 was $2.7 million, or $0.24 per share, compared to a net loss attributable to common stockholders of $2.4 million, or $0.29 per share, for the same period in 2018. Navidea’s net loss attributable to common stockholders for the first six months of 2019 was $5.1 million, or $0.48 per share, compared to a net loss attributable to common stockholders of $9.1 million, or $1.12 per share, for the same period in 2018.

Navidea ended the second quarter of 2019 with $5.3 million in cash and investments.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

Event:

Q2 2019 Earnings and Business Update Conference Call

Date:

Thursday, August 8, 2019

Time:

5:00 p.m. (EDT)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13693119

Webcast Link: View Source

The recorded conference call can be replayed and will be available for 90 days following the call, available on the investor relations page of Navidea’s corporate website at www.navidea.com.

On August 8, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, Selecta Biosciences, AUG 8, 2019, View Source [SID1234538441]).

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"Our gene therapy program has gained a lot of momentum, most notably with our new strategic partnership with AskBio, which will combine our ImmTOR platform technology with AskBio’s AAV technology and know-how. We believe this partnership will allow us to develop a robust pipeline of products that can potentially be re-dosed and offer patients a new treatment paradigm in areas of high unmet need," said Carsten Brunn, Ph.D., President and CEO of Selecta. "We are also pleased that the COMPARE trial continues to actively enroll patients, and we look forward to differentiating SEL-212 compared to the current FDA-approved uricase therapy in adult patients with chronic refractory gout. We believe the clinical profile of SEL-212, along with its more convenient monthly dosing, makes it a compelling product for patients and their providers and represents a very large market opportunity of over $1.0 billion."

Recent Highlights and Anticipated Upcoming Milestones

Chronic Refractory Gout Program:

COMPARE Clinical Trial of SEL-212 vs. Krystexxa Enrolling Patients: In March 2019, Selecta initiated a six-month head-to-head clinical trial (COMPARE) designed to evaluate the superiority of its lead product candidate, SEL-212 (ImmTOR + Pegadricase), compared to Krystexxa, the current U.S. Food and Drug Administration (FDA)-approved uricase therapy, in adult patients with chronic refractory gout. The COMPARE trial, which is currently enrolling patients, is expected to enroll 150 patients, and the primary endpoint is the maintenance of serum uric acid (sUA) levels of <6mg/dL at six months. An interim data analysis is expected in the fourth quarter of 2019 with a full statistical superiority analysis expected in the second quarter of 2020.
AAV Gene Therapy Program:

New Strategic Partnership with Gene Therapy Leader AskBio: In August 2019, Selecta announced a strategic partnership with Asklepios BioPharmaceutical, Inc. (AskBio), to jointly develop, manufacture and commercialize a broad portfolio of life-changing, next-generation adeno-associated virus (AAV) gene therapies. This partnership will leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential for re-dosing in patients.
Advancing Collaboration with CureCN Consortium: Under a collaboration with the European consortium, CureCN, for an ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome, Selecta expects CureCN to obtain scientific advice from the German drug regulatory authority in the second half of 2019.
Corporate Updates:

Strengthened Management Team: Selecta announced the appointment of Alison Schecter, M.D., as Chief Medical Officer in July 2019. Dr. Schecter has over 20 years of combined drug development, strategic management and practical clinical experience in academia and industry and joins Selecta from Sanofi, where she was the Global Project Head, Rare Diseases, and was responsible for leading the Niemann-Pick Disease (ASMD) project.
Expanded Board of Directors: Selecta announced the addition of Scott D. Myers to its Board of Directors, in June 2019. Mr. Myers has more than 20 years of leadership experience in the biopharmaceutical industry and currently serves as Chief Executive Officer and Chairman of the Board of Rainier Therapeutics.
Second Quarter 2019 Financial Results:

Revenue: For the second quarter ended June 30, 2019, the company recognized less than $0.1 million of revenue under its collaboration agreement with Spark.

Research and Development Expenses: Research and development expenses for the second quarter ended June 30, 2019 were $12.1 million, which compares with $14.4 million for the second quarter of 2018. Research and development expenses decreased by $2.3 million, or 16%, as compared to the same period in 2018. The decrease reflects the reduced salaries and benefits as a result of the company’s headcount reduction at the beginning of fiscal 2019. There were further cost reductions related to discontinued programs. These cost reductions were offset by the timing of costs incurred for both the company’s Phase 2 and Phase 3 clinical programs for SEL-212.

General and Administrative Expenses: General and administrative expenses for the second quarter ended June 30, 2019 were $4.1 million, which compares with $4.4 million for the second quarter of 2018. General and administrative expenses decreased by $0.3 million, or 6%, as compared to the same period in 2018. The reduction in costs was primarily the result of reduced legal fees, offset by an increase in professional fees.

Net Loss: For the second quarter ended June 30, 2019, Selecta reported a net loss of $16.4 million, or $0.37 per share, compared to a net loss of $18.8 million, or $0.84 per share, for the same period in 2018.

Cash Position: Selecta had $42.0 million in cash, cash equivalents, restricted cash and short-term investments as of June 30, 2019, which compares to cash, cash equivalents, restricted cash and short-term investments of $48.7 million as of March 31, 2019.
Financial Outlook:

Selecta believes its available cash, cash equivalents and restricted cash will be sufficient to meet its operating requirements into the first quarter of 2020.

Conference Call and Webcast Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company’s second quarter 2019 financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10127459.